The longitudinal association between the use of antihypertensive medications and 24-hour sleep in nursing homes: results from the randomized controlled COSMOS trial.

BACKGROUND: Antihypertensive medication use and sleep problems are highly prevalent in nursing home patients. While it is hypothesized that blood pressure and antihypertensive medication use can affect sleep, this has not been investigated in depth in this population. Alongside a multicomponent intervention including a systematic medication review, we aimed to investigate the longitudinal association between antihypertensive medication use, blood pressure and day- and night-time sleep over 4 months. METHODS: This study was based on secondary analyses from the multicomponent cluster randomized controlled COSMOS trial, in which the acronym denotes the intervention: COmmuncation, Systematic pain assessment and treatment, Medication review, Organization of activities and Safety. We included baseline and 4-month follow-up data from a subgroup of nursing home patients who wore actigraphs (n = 107). The subgroup had different levels of blood pressure, from low (< 120) to high (≥ 141). Assessments included blood pressure, antihypertensive medication use, and sleep parameters as assessed by actigraphy. RESULTS: We found a significant reduction in total sleep time at month four in the intervention group compared to the control group. When analysing the control group alone, we found a significant association between antihypertensive medication use and increased daytime sleep. We also found negative associations between blood pressure, antihypertensive medication use and sleep onset latency in the control group. CONCLUSIONS: Our results suggest a correlation between excessive daytime sleep and antihypertensive medication use. These findings should be followed up with further research, and with clinical caution, as antihypertensive medications are frequently used in nursing homes, and sleep problems may be especially detrimental for this population. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov ( NCT02238652 ).

The Effect of a Multicomponent Intervention on Quality of Life in Residents of Nursing Homes: A Randomized Controlled Trial (COSMOS).

OBJECTIVES: To investigate if the multicomponent intervention of the COSMOS trial, combining communication, systematic pain management, medication review, and activities, improved quality of life (QoL) in nursing home patients with complex needs. DESIGN: Multicenter, cluster-randomized, single-blinded, controlled trial. SETTING: Thirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities. PARTICIPANTS: Seven hundred twenty-three patients with and without dementia (≥65 years) were cluster randomized to usual care or intervention in which health care staff received standardized education and on-site training for 4 months with follow-up at month 9. MEASUREMENTS: Primary outcome was change in QoL as measured by QUALIDEM (QoL dementia scale); QUALID (QoL late-stage dementia scale), and EQ-VAS (European QoL-visual analog scale) from baseline to month 4. Secondary outcomes were activities of daily living (ADL), total medication, staff distress, and clinical global impressions of change (CGIC). RESULTS: During the active intervention, all 3 QoL measures worsened, 2 significantly (QUALID P = .04; QUALIDEM P = .002). However, follow-up analysis from month 4 to 9 showed an intervention effect for EQ-VAS (P = .003) and QUALIDEM total score (P = .01; care relationship P = .02; positive affect P = .04, social relations P = .01). The secondary outcomes of ADL function, reduction of medication (including psychotropics) and staff distress, improved significantly from baseline to month 4. Intervention effects were also demonstrated for CGIC at month 4 (P = .023) and 9 (P = .009), mainly because of deterioration in the control group. CONCLUSION AND IMPLICATIONS: Temporarily, the QoL decreased in the intervention group, leading to our hypothesis that health care staff may be overwhelmed by the work-intensive COSMOS intervention period. However, the decrease reversed significantly during follow-up, indicating a potential learning effect. Further, the intervention group improved in ADL function and received less medication, and staff reported less distress and judged COSMOS as able to bring about clinically relevant change. This suggests that nonpharmacologic multicomponent interventions require long follow-up to ensure uptake and beneficial effects.